Guidelines for Pharmacovigilance Recall Procedures

1) Purpose

The purpose of this SOP is to establish procedures for the recall of pharmaceutical products from the market in response to pharmacovigilance data indicating potential safety risks.

2) Scope

This SOP applies to all pharmacovigilance and quality assurance personnel involved in the recall process, including pharmacovigilance managers, regulatory affairs specialists, and quality control officers.

3) Responsibilities

The Recall Management Team is responsible for coordinating and executing recall procedures. The Pharmacovigilance (PV) Manager oversees recall activities to ensure they are conducted in compliance with regulatory requirements and company policies.

4) Procedure

4.1 Initiation of Recall

1. Identify the need for a recall based on pharmacovigilance data, adverse event reports, or regulatory notifications.
2. Notify senior management and regulatory authorities of the decision to initiate a recall.
3. Form a Recall Management Team comprising pharmacovigilance, regulatory affairs, quality assurance, and supply chain representatives.

4.2 Recall Classification

1. Determine the classification of the recall (Class I, II, or III) based on the severity of the risk to patients.
2. Document the rationale for the recall classification and obtain approval from the PV Manager and regulatory affairs.

4.3 Notification and Communication

1. Prepare and distribute recall notifications to healthcare providers, distributors, and regulatory authorities.
2. Provide clear instructions for the return or destruction of the recalled product.
3. Maintain open lines of communication with all stakeholders throughout the recall process.

4.4 Product Retrieval

1. Coordinate with supply chain and distribution teams to retrieve the recalled product from the market.
2. Ensure proper documentation and tracking of returned products.
3. Conduct inspections of returned products to assess compliance with recall instructions.

4.5 Root Cause Analysis

1. Conduct a thorough investigation to determine the root cause of the issue leading to the recall.
2. Document findings and implement corrective and preventive actions (CAPAs) to prevent recurrence.
3. Review and update relevant SOPs, processes, and training materials based on investigation outcomes.

4.6 Reporting and Documentation

1. Prepare and submit recall reports to regulatory authorities, detailing the scope, classification, and outcome of the recall.
2. Maintain records of all recall-related activities, communications, and documents for audit and inspection purposes.
3. Conduct post-recall reviews to assess the effectiveness of the recall process and identify areas for improvement.

5) Abbreviations, if any

PV – Pharmacovigilance, SOP – Standard Operating Procedure, CAPA – Corrective and Preventive Actions

6) Documents, if any

Recall notifications, recall classification documentation, product return logs, root cause analysis reports, CAPA records.

7) Reference, if any

FDA Guidance for Industry – Product Recalls, Including Removals and Corrections, EU Guidelines on Good Distribution Practice (GDP) of Medicinal Products for Human Use.

8) SOP Version

Version 1.0